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新冠疫情期间抑郁症状青年使用心理健康聊天机器人:单盲、三臂随机对照试验。

Mental Health Chatbot for Young Adults With Depressive Symptoms During the COVID-19 Pandemic: Single-Blind, Three-Arm Randomized Controlled Trial.

机构信息

Institute of Applied Psychology, College of Education, Tianjin University, Tianjin, China.

Laboratory of Suicidology, Tianjin Municipal Education Commission, Tianjin, China.

出版信息

J Med Internet Res. 2022 Nov 21;24(11):e40719. doi: 10.2196/40719.

Abstract

BACKGROUND

Depression has a high prevalence among young adults, especially during the COVID-19 pandemic. However, mental health services remain scarce and underutilized worldwide. Mental health chatbots are a novel digital technology to provide fully automated interventions for depressive symptoms.

OBJECTIVE

The purpose of this study was to test the clinical effectiveness and nonclinical performance of a cognitive behavioral therapy (CBT)-based mental health chatbot (XiaoE) for young adults with depressive symptoms during the COVID-19 pandemic.

METHODS

In a single-blind, 3-arm randomized controlled trial, participants manifesting depressive symptoms recruited from a Chinese university were randomly assigned to a mental health chatbot (XiaoE; n=49), an e-book (n=49), or a general chatbot (Xiaoai; n=50) group in a ratio of 1:1:1. Participants received a 1-week intervention. The primary outcome was the reduction of depressive symptoms according to the 9-item Patient Health Questionnaire (PHQ-9) at 1 week later (T1) and 1 month later (T2). Both intention-to-treat and per-protocol analyses were conducted under analysis of covariance models adjusting for baseline data. Controlled multiple imputation and δ-based sensitivity analysis were performed for missing data. The secondary outcomes were the level of working alliance measured using the Working Alliance Questionnaire (WAQ), usability measured using the Usability Metric for User Experience-LITE (UMUX-LITE), and acceptability measured using the Acceptability Scale (AS).

RESULTS

Participants were on average 18.78 years old, and 37.2% (55/148) were female. The mean baseline PHQ-9 score was 10.02 (SD 3.18; range 2-19). Intention-to-treat analysis revealed lower PHQ-9 scores among participants in the XiaoE group compared with participants in the e-book group and Xiaoai group at both T1 (F=17.011; P<.001; d=0.51) and T2 (F=5.477; P=.005; d=0.31). Better working alliance (WAQ; F=3.407; P=.04) and acceptability (AS; F=4.322; P=.02) were discovered with XiaoE, while no significant difference among arms was found for usability (UMUX-LITE; F=0.968; P=.38).

CONCLUSIONS

A CBT-based chatbot is a feasible and engaging digital therapeutic approach that allows easy accessibility and self-guided mental health assistance for young adults with depressive symptoms. A systematic evaluation of nonclinical metrics for a mental health chatbot has been established in this study. In the future, focus on both clinical outcomes and nonclinical metrics is necessary to explore the mechanism by which mental health chatbots work on patients. Further evidence is required to confirm the long-term effectiveness of the mental health chatbot via trails replicated with a longer dose, as well as exploration of its stronger efficacy in comparison with other active controls.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2100052532; http://www.chictr.org.cn/showproj.aspx?proj=135744.

摘要

背景

抑郁症在年轻人中发病率很高,尤其是在 COVID-19 大流行期间。然而,全球的心理健康服务仍然稀缺且未得到充分利用。心理健康聊天机器人是一种新颖的数字技术,可以为抑郁症状提供完全自动化的干预。

目的

本研究旨在测试基于认知行为疗法 (CBT) 的心理健康聊天机器人 (XiaoE) 在 COVID-19 大流行期间对有抑郁症状的年轻人的临床效果和非临床性能。

方法

在一项单盲、3 臂随机对照试验中,从中国一所大学招募有抑郁症状的参与者,随机分配到心理健康聊天机器人 (XiaoE; n=49)、电子书 (n=49) 或通用聊天机器人 (Xiaoai; n=50) 组,比例为 1:1:1。参与者接受为期 1 周的干预。主要结局是根据第 9 项患者健康问卷 (PHQ-9) 在 1 周后 (T1) 和 1 个月后 (T2) 抑郁症状的减少。在协方差分析模型中,对基线数据进行调整,进行意向治疗和符合方案分析。对缺失数据进行了受控多重插补和基于 δ 的敏感性分析。次要结局是使用工作联盟问卷 (WAQ) 测量的工作联盟水平、使用用户体验精简可用性度量 (UMUX-LITE) 测量的可用性和使用可接受性量表 (AS) 测量的可接受性。

结果

参与者平均年龄为 18.78 岁,37.2%(55/148)为女性。基线 PHQ-9 评分平均为 10.02(SD 3.18; 范围 2-19)。意向治疗分析显示,与电子书组和 Xiaoai 组相比,XiaoE 组的参与者在 T1(F=17.011; P<.001;d=0.51)和 T2(F=5.477; P=.005;d=0.31)的 PHQ-9 评分更低。与 XiaoE 相比,工作联盟 (WAQ; F=3.407; P=.04) 和可接受性 (AS; F=4.322; P=.02) 更好,而在可用性 (UMUX-LITE; F=0.968; P=.38) 方面,各组之间没有显著差异。

结论

基于 CBT 的聊天机器人是一种可行且引人入胜的数字治疗方法,可为有抑郁症状的年轻人提供便捷的可及性和自我引导的心理健康帮助。本研究建立了一种针对心理健康聊天机器人的非临床指标的系统评估。未来,有必要同时关注临床结果和非临床指标,以探索心理健康聊天机器人对患者的作用机制。需要进一步的证据通过复制更长剂量的试验来确认心理健康聊天机器人的长期效果,并探索其与其他活性对照相比的更强疗效。

试验注册

中国临床试验注册中心 ChiCTR2100052532;http://www.chictr.org.cn/showproj.aspx?proj=135744。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/383e/9680932/afa48648c7ea/jmir_v24i11e40719_fig1.jpg

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